Trials / Completed
CompletedNCT03474107
A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 608 (actual)
- Sponsor
- Astellas Pharma Global Development, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy. This study compared progression-free survival on study therapy (PFS1); the overall response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 of participants treated with EV to participants treated with chemotherapy. In addition, this study evaluated the duration of response (DOR) per RECIST V1.1 of EV and chemotherapy and assessed the safety and tolerability of EV, as well as, the quality of life (QOL) and Patient Reported Outcomes (PRO) parameters.
Detailed description
Japan PMDA has approved enfortumab vedotin (Padcev) for the treatment of advanced urothelial cancer. The study will continue as a post marketing study in Japan. Participants considered an adult according to local regulation at the time of obtaining informed consent participated in the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Enfortumab Vedotin | Intravenous infusion |
| DRUG | Docetaxel | Intravenous infusion |
| DRUG | Vinflunine | Intravenous infusion |
| DRUG | Paclitaxel | Intravenous infusion |
Timeline
- Start date
- 2018-06-27
- Primary completion
- 2020-07-15
- Completion
- 2025-11-27
- First posted
- 2018-03-22
- Last updated
- 2026-01-09
- Results posted
- 2021-08-24
Locations
158 sites across 19 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Netherlands, Portugal, Russia, South Korea, Spain, Switzerland, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03474107. Inclusion in this directory is not an endorsement.